An Investigation Into the Efficacy of Herpecin L at Reducing the Frequency and Severity of Cold Sores

April 1, 2023 updated by: Focus Consumer Healthcare
Focus Consumer Healthcare has developed Herpecin L. Herpecin L combines many different ingredients hypothesized to promote quick healing and symptom reduction from cold sores.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Monica, California, United States, 90404
        • Citruslabs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male Female between 18-60 years of age.
  • Must be in good health with no significant chronic conditions and a BMI under 35.
  • Must experience regular cold sores or fever blisters
  • Must agree to avoid daily lip balm or another product designed to alleviate their cold sore (e.g., Abreva or other over-the-counter cold sore products).

Exclusion Criteria:

  • Suffers from pre-existing conditions that would prevent them from adhering to the protocol including chronic conditions such as oncological or psychiatric disorders.
  • Anyone with known severe allergic reactions.
  • Unwilling to follow the study protocol.
  • Currently pregnant, breastfeeding, or wanting to become pregnant for the duration of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Herpecin L
Participants will use Herpecin L Everyday Protection lip balm.
Other: Herpecin L
Participants in the Herpecin L arm will use the test product daily as a preventive product by applying the product twice daily. Also, participants will be told they can reapply the product if going outside into the cold, wind, or sun. If participants in the Herpecin L arm do experience a cold sore or fever blister, they will be instructed to use the product at the first sign of the cold sore and then at least four more times during the day until the cold sore is gone (they can use the product more often if they plan to go outside into the cold, sun, or wind).
No Intervention: Controlled Arm
Participants will not use any cold sore products or lip balms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary aim of this research is to understand the changes in cold sore severity.
Time Frame: 12 weeks
Cold sore severity will be measured via survey and cold sore severity grading. Symptom severity is rated on a scale of 0 (Not a problem) to 6 (Severe)
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The secondary objective of this trial is to examine differences in cold sore frequency between the two groups.
Time Frame: 12 weeks
Cold sore frequency will be measured via a self-reported survey measuring the frequency of cold sore occurrence during the study period compared to baseline.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Focus Consumer Healthcare

Collaborators

Citruslabs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2023

Primary Completion (Actual)

January 26, 2023

Study Completion (Actual)

February 20, 2023

Study Registration Dates

First Submitted

March 9, 2023

First Submitted That Met QC Criteria

April 1, 2023

First Posted (Actual)

April 3, 2023

Study Record Updates

Last Update Posted (Actual)

April 3, 2023

Last Update Submitted That Met QC Criteria

April 1, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20274

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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